FDA 의료기기 리콜
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Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and…
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of t…
FDA 리콜 보기 →Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur…
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
FDA 리콜 보기 →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
FDA 리콜 보기 →Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstr…
FDA 리콜 보기 →Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod…
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected t…
FDA 리콜 보기 →INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. …
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss o…
FDA 리콜 보기 →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN …
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
FDA 리콜 보기 →5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may …
FDA 리콜 보기 →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBO…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
FDA 리콜 보기 →Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: …
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, all…
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